The TGA is aware of products being sold in Australia that claim to contain, or influence the levels of, nicotinamide adenine dinucleotide (NAD, NAD+, NADH) or nicotinamide mononucleotide (NMN) in the body.
Information for sponsors and product owners
What do I need to be aware of?
All medicines supplied in, imported into, or exported from Australia must be entered in the Australian Register of Therapeutic Goods (ARTG) unless exempted or otherwise authorised by the TGA. They can be either registered or listed in the ARTG.
If you are a sponsor of a listed medicine, you should be aware that NAD and NMN are currently not permitted ingredients. Further, listed medicines that make claims about NAD or NMN through their name, labelling or advertising are at risk of breaching the law, particularly if those claims imply or suggest that the medicine contains NAD or NMN.
If you are advertising or supplying therapeutic goods that refer to NAD or NMN, and these goods are not included in the ARTG nor exempted or otherwise authorised, you are likely breaching the law. This may result in compliance or enforcement action by the TGA.
Where can I find more information?
- Permissible ingredients for listed and assessed listed medicines
- Permitted indications for listed medicines
- Labelling and packaging for medicines and biologicals
- How to advertise therapeutic goods
What do I need to do?
Please carefully review the information above.
If you are supplying a listed medicine referring to NAD or NMN through its name, label, advertising and/or any other form of presentation, you should:
- Check its compliance with the applicable legislative requirements.
- Stop the supply of any medicine(s) that do not meet these requirements.
- Remove any unlawful advertising (including advertising on website, blog and/or social media pages) that refer to such substances.
- Take steps to make sure future batches of the medicine(s) comply.
If you are supplying an unapproved therapeutic good referring to NAD or NMN, please refer to Supply an unapproved therapeutic good (sponsors).
Information for consumers
What do I need to be aware of?
Generally, all medicines sold in Australia must be entered in the Australian Register of Therapeutic Goods (ARTG). They can be either registered or listed in the ARTG. You can tell if a medicine is in the ARTG by looking for the AUST L, AUST L(A), or AUST R number on the product label and/or by searching the ARTG on our website.
Listed medicines (‘AUST L’) can only make low-level health claims selected from a pre-approved list and can only use ingredients that the TGA has pre-assessed as safe and of low risk. Be aware that NAD and NMN are currently not approved for use as ingredients in listed medicines.
Therapeutic goods not included in the ARTG are called ‘unapproved goods’. These goods have not been evaluated for quality, safety, or effectiveness by the TGA. Be aware that products making claims about NAD, NAD+, NADH or NMN that do not have an AUST number on their label may be unapproved goods or illegally supplied and could pose a risk to your health. Please also be aware that there are risks with buying health products online.
What can I do?
- If you have concerns about a medicine you are taking, you can report it to us.
- If you think you may be experiencing a side effect after using a medicine, seek advice from a health professional. You or your health professional can then report it to us.
Detailed information on how and what to report is available at Report a problem or side effect.
What the TGA will do
The TGA’s regulatory scheme is critical to the safety of Australian consumers.
Where issues of non-compliant products come to our attention, in the first instance, the TGA will often work with the responsible entity (e.g. sponsor or product owner) to provide advice and education for that entity to take the necessary action to achieve compliance. However, escalation of regulatory action will be considered if:
- the entity has repeat breaches and is not willing to comply, and/or
- the alleged breach is such that there is a likely impact on a consumers' ability to use therapeutic goods safely or appropriately.
Refer to Compliance actions and outcomes for further information on our compliance and enforcement tools, as well as the outcomes of compliance actions.